The Use of Progesterone to Reduce Preterm Birth

This study has been completed.

Sponsor:

University of Mississippi Medical Center

ClinicalTrials.gov Identifier:

NCT00830765

First Posted: January 28, 2009

Last Update Posted: February 20, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Preterm birth is the most common and costly complication in obstetrics. It complicates up to 11 % of all pregnancies and it is responsible for 70% of sick babies. Recently two studies have shown that giving progesterone (a normal hormone made by the ovaries) prolongs gestation in women who have had a preterm birth in an earlier pregnancy (and therefore are at risk for another early delivery). There are other studies that show that this technique of giving a weekly shot of progesterone does not prevent preterm birth. In addition, There are other groups of patients who are at very high risk for preterm birth which have not been studied. They include: 1.) Cervical cerclage (a stitch in the mouth of the womb); 2.) Multifetal gestation (twins, triplets, etc.); 3.) Women with preterm (<34 weeks) rupture of the membranes; 4.) Women with preterm labor during the current pregnancy with intact membranes who have been tocolyzed (have their labor stopped and are getting ready to go home). We purpose to give weekly shots of progesterone or a placebo in a randomized fashion to women in the first group who are at risk for preterm delivery due to an early birth in a previous pregnancy as well as the other four groups listed. If progesterone given weekly is successful at preventing early delivery as compared to the placebo group then great benefit for these women as well as future pregnancies would be accrued.

The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.

Drug: Placebo

2cc of placebo liquid formulated by pharmacy personnel at the University of Mississippi Medical Center injected IM weekly until 34 weeks' gestation has been reached or delivery, whichever occurs first.

Active Comparator: Progesterone

The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.

Drug: Progesterone (OHP17)

100mg of OHP17 or comparable amount of placebo administered by IM injection weekly until either 34 weeks' gestation or delivery has been achieved, whichever occurs first.

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